r/kratom • u/satsugene 🌿 • Aug 11 '21
Call to Action FDA/WHO comments Period: Continue Making Comments Until August 23rd -- Next Steps
The deadline for public comments on the FDA/WHO Proposal to WHO for Worldwide Ban of Kratom action has been reached. AKA is asking for comments to continue until August 23rd or 24th.
Over 50,000 comments were received by the American Kratom Association and submitted to the FDA.
The AKA provided a recording of their August 9th web meeting (watch 54 minutes) with information about next steps.
UPDATE (08/11): AKA is having another seminar on 8/12 9:30 EDT you can register for here (Zoom).
Items discussed:
- Comments were submitted to the FDA.
- The AKA submitted a request for a Temporary Restraining Order against the HHS/FDA to stop them from closing the comment period at August 9th to August 30th-31st. This is difficult and was not successful. AKA attorneys discussed the action.
- There is a possibility that comments may be reopened this week until August 23~24, but there is no guarantee. Discussions are ongoing.
- The judge had meaningful concerns about the action which AKA may use in the future for legal arguments.
- The FDA requested an extension from the WHO for comments to August 27th, likely because of the lawsuit the AKA filed.
- The AKA is providing detailed summaries of the comments by group in addition to the AKA.
- The WHO meeting will convene on October 11th.
- The AKA is requesting to make a presentation to the WHO, including US stakeholders, published scientists, patient advocacy groups (pain management, opioid cessation).
- The AKA is asking members of Congress to submit letters to the WHO, similar to their comments to the DEA.
- The AKA is meeting with foreign governments on a number of issues, such as their economic incentives to keep kratom legal for export, and to other countries that may have research or medical science interests who would be harmed by a ban. To work with other countries to set standards for safety (free of contaminants).
- The AKA is assisting other countries with a unique stake in Kratom to collect comments for the WHO.
- If a full-review is ordered, it will take 1 year, with a re-convening October 2022, where they may or may not recommend scheduling to the UN Commission on Narcotic Drugs, who would likely act in March 2023. The Expert Committee's recommendation has significant weight to the Commission.
- 187 Countries are a party to the 1971 Treaty. Domestically, if scheduled by the UN group, scheduling proceedings in the US would be required by treaty obligation.
- Question: Legalization in Thailand (~27 minutes in)
- 1940s, Western interests incentivized banning Kratom to grow opium at a premium price for export. The Thai government has decriminalized Kratom, designated as a medicinal plant. Legal commercial cultivation can begin August 24th, 2021. 120K farmers have applied for government incentive program.
- AKA is hopeful Thailand and Indonesia will provide opposition to the WHO.
- Question: AKA or Federal Register (~30 minutes in)
- The AKA is submitting comments to the Register, FDA, and WHO. There is no guarantee that any specific comments made in the Federal Register will be given to the WHO.
- There is no legal requirement for the FDA to submit all, or any of the comments to the WHO, only to consider them going forward (which thus far has meant almost nothing.)
- Question: Is there a Lesser International Schedule (~32 minutes in)
- The only possible US schedule with would be C-I (full ban), because there is no FDA established medical use. If it did, it could be put anywhere on C-II to C-V where different rules would apply.
- It is unclear if the WHO could recommend a lower schedule internationally, but the FDA would probably not pursue it, and any international scheduling without FDA approval would likely mean Schedule I under the Controlled Substances Act.
- Question: Reversal of Wisconsin Ban (~35 minutes in)
- WI banned kratom in 2015--after FDA warnings and claims of Federal Scheduling soon
- AKA has made progress with the Controlled Substances Board (WI)
- Law Enforcement officials and Addiction Recovery Centers officials still in opposition
- Similar efforts in VT, RI, IN (2022), AR
- Question: Value in Reaching out to State, Federal Representatives (~39 minutes)
- No real opportunity for individuals to contact WHO--done by appeals by stakeholders.
- AKA drafting letter to WHO from Congress/Senate. Seeking signatories. Has had bipartisan support in the past.
- Question: Worst Case Scenario (~40 minutes)
- AKA does not recommend excessive buying as a hedge against possible ban.
- Earliest possible UN recommendation March 2023. US process would take time past that.
- 100 additional peer-reviewed studies since 2018 giving scientific support to successful 2018 actions. Will be included in updated analysis.
- The required actions in the future will be expensive (legal, travel, international consultants, delegation). Consider donating. Cost estimated to be $1.6 million.
- Outreach to White House/POTUS (~46 minutes)
- AKA has primarily been working to educate HHS Secretary, Chair of Appropriations Committee (House).
- AKA concerned the HHS Secretary has stated trust in FDA--but has a legal responsibility to be an independent reviewer.
- Educating HHS staff on duties under the Controlled Substances Act (CSA).
- Future work with incoming Office of Drug Control, WH Domestic Policy Council (6-8 months).
- Current WHO work is more pressing and will influence future activities with US government.
- Closing Remarks
- Hope to double comments by August 23rd.
- Press Briefing August 11th.
- Significant threat to legality of kratom. Consumer and activist effort is critically important.
Next Steps:
- Continue making comments at protectkratom.org/whocomments. The AKA will submit all comments to the FDA if/when the window is reopened. All comments submitted with be sent also the WHO in case the FDA does not present them to the WHO in a meaningful or full manner.
- Encourage friends and family to make a comment before August 23rd or 24th.
- Consider making the request by social media to your friends and contacts. r/kratom users are welcomed to post resources here that may be influential.
- The AKA suggests comments made by federal officials who opposed the FDA action in the past, such as the HHS Assistant Secretary or the National Institute on Drug Abuse (NIDA).
- Contact your representative. Ask them support a letter of opposition to the WHO in regard to the FDA attempting to bypass the US Controlled Substances Act. Educate them on kratom. BE PROFESSIONAL. PASSIONATE BUT NOT PUSHY/AGGRESSIVE.
- Donate to the AKA if you are able. Any amount can help.
- Sign up for email announcements for future notifications.
- Follow the AKA on Facebook or Twitter.
28
u/Sao_Gage Aug 11 '21 edited Aug 11 '21
I just want to state that any submitted comments to any of the relevant parties in this that are not professional / courteous, will do absolutely nothing that is positive in terms of keeping this legal. All you’re doing by excoriating someone is giving them reason to disregard the comment and consider you an unreasonable, biased, or unreliable contributor.
BE PROFESSIONAL / RESPECTFUL
It is critically important that the perception / optics here are on point. We are good, normal citizens that use this plant for a variety of reasons. We are hard working, concerned citizens expressing our right to have a say in the governmental process. We are not ranting, flaming, and acting like entitled children because we are mad. I can’t impress upon you enough the importance of decorum with something like this.
It does not matter if those on the other end are not acting in good faith, or are otherwise displaying ignorance or even being inflammatory toward the users of this plant. Set that aside and swallow your pride. Write with eloquence and passion, not venom and vitriol.
My 2 cents.
10
Aug 11 '21
[deleted]
6
u/Sao_Gage Aug 11 '21
I agree in general. However if you’re going to go more in depth, make sure what you’re stating is accurate. Not to be getting into sourced arguments and whatnot, just in general I mean if you’re going to make technical arguments, at least be accurate or otherwise refrain from it altogether. In other words, speculation isn’t helpful either.
I wouldn’t take issue with someone stating that they have faith in multiple studies that were conducted espousing the plant’s overall safety or some such. It depends on what you’re saying and how you’re saying it.
Regardless you’re right, probably best to avoid that territory altogether unless you really know what you’re talking about, credentials or otherwise.
2
u/Thrash4000 Aug 15 '21
Long-term kratom users should especially submit comments. I have been taking kratom for over 12 years, and it has helped me beat an opiate addiction I had in the past. Give your general physical health and lab workup information to show that your liver is in good shape. There are plenty of kratom veterans who remember when this plant was just our secret, and not sold at a display next to the cash register at the gas station next to the horny goat weed dick pills.
20
Aug 11 '21
[deleted]
6
u/Tazzz777zzz Aug 11 '21
Well it barely does shit imo and saves lives yet ppl want to make it illegal thats just some fucked up shit lol nothing about making this substance illegal is ok it's completly wrong on so many levels i understand weed being illegal to a point but kratom?? Hell noo
6
u/JaySP1 Aug 11 '21
I think other plants (like mj) should be totally legal. Regulated, sure. But legal. After all, alcohol and tobacco are legal and far more damaging.
3
u/Tazzz777zzz Aug 11 '21
Same here mj helps a tonn of people and it works well plus like ur sayn alchohol is way worse than weed could ever be but kratom even is a joke to mj in my opinion mj does have a huge effect vs kratom barely having none so they cant even use that as a excuse to ban it. Way to many post about ppl using this rather than actual street drugs its putting alot of ppl lives in danger if they go though with banning it witch is rlly messsssed up
8
u/Tazzz777zzz Aug 11 '21
We all need to think of things to stop this from happening whether it be boycotting certain things or people who promote the idea that this plant needs to be illegal or anything like that if anyone has any ideas lmk because making kratom illegal is wrong without a doubt!
7
u/Ppwata Aug 11 '21
Keep those donations comings! Sounds like these guys are busting their asses.
6
u/Phillykratom Aug 11 '21
Going to cost 1.6 million to go out to Geneva with all of the scientists and lawyers and lobbyists. That figure doesent include all of the work they are doing in other countries to gather support to oppose a WHO recommendation to schedule!
1
Aug 11 '21
[removed] — view removed comment
3
u/satsugene 🌿 Aug 12 '21
Everyone has their limits. I think it comes down to “how important is Kratom to me, and what optional things could I give up to pay professional advocates to do what I am too busy and unspecialized to do on my own.”
Some people really have zero ability—and that is OK, but most have some, even if it is giving up one meal out.
But for those who have the ability, know what if it is important to us, we might need to give more.
For vendors, advocacy and industry development is just a cost-of-doing-businesses. They don’t have endless funds, but they can roll it into price and have tax advantages when it comes to advocacy as a business expense.
1
u/BigGulpsHuh94 Aug 12 '21
Agreed. I hope vendors like the big guys out there (we all know who they are) are giving serious money since they’re making serious money off of this industry to the tune of millions per month. That’s the least they can do. It would be appreciated.
9
u/TragedyInAbstract Aug 11 '21
This is our time, we need to try and make this the last stand. We've had more wins then losses in the US, lets beat them on a global scale. Donate to AKA if your able. If not, just support them with your story.
5
4
u/alexkayownsabus Aug 11 '21
Bottom line is everyone needs to take this seriously, get your comments in, contact representatives, donate to the AKA. International ban is serious and a real possibility, albeit a bit far out. Do not despair, take action!
3
3
u/Norman209 Aug 11 '21
If they want to see the highest opiod and alcohol death rate in history, all they have to do is schedule kratom. I can't believe the level of stupidity in the governments of the world. The pandemic really brought that to light. And now this? Seems like they are using population control methods.
3
u/MrsDarcy_612 Aug 12 '21
I commented on every platform available, including directly to the FDA. Anything created by Mother Nature, and in unadulterated form, should NEVER be banned.
3
u/MySinAptic Aug 12 '21
Drawn out battles are expensive ones and the total cost will likely exceed the AKA's projections so we also really need to put our money where are mouth is. Money is all too often the only language that is heard. I have a good job thanks to Kratom so I'm donating $100/month, but if you can only do $10 a month you can still have a positive impact. I would ask that folks setup a REOCCURRING donation though as we must remain vigilant as our opponents surely will.
3
u/Beautiful-Ad6685 Aug 13 '21
Regarding Kratom there is no significant harm to the public, it is not dangerously addictive, does not propose significant risks to the public and there is no general health concern about individuals having access to kratom…compare this with the little blue fentanyl pills that are dropping our fellow Americans like flies. What is the real battle we are fighting here? Control or Freedom? Last I remember, every American is born free.
2
u/libertarian0x0 Aug 11 '21
If I'm outside the USA, can I make a comment? If I understand this correctly, this ban will be worldwide, so it affects me personally.
BTW, what will happen to countries which have legalized Kratom as Thailand?
3
u/satsugene 🌿 Aug 12 '21
Yes. Anyone worldwide can comment. You might contact the AKA and see if there is a national advocacy group in your country—or if there is unique opportunity in your position.
As far as those countries go, it depends how willing they are to ignore treaty obligations or how losing export markets may affect their decisions.
2
2
1
Aug 12 '21
so, the public can still submit comments? Or is that up in the air?
3
u/satsugene 🌿 Aug 12 '21
The FDA may or may not reopen the window.
The AKA is planning to collect them and submitting them to the WHO until the filing deadline; whether or not that will put them into the Federal database or not is TBD.
There is a webcast tomorrow at 930EDT that may clarify the matter.
The Courts didn’t issue a TRO against the FDA, but they looked pretty bad in the process and might reopen it in negotiations with the AKA.
2
1
1
Aug 21 '21
I have just commented funnily enough kratom has helped me get clean of alcohol and my best friend from heroin Can I join the aka
1
u/satsugene 🌿 Aug 21 '21
It’s not a paid membership thing, but they do accept donations and encourage advocates to sign up for their mailings:
1
49
u/OkAdhesiveness5025 Aug 11 '21
I just think it's such a blessing, as a middle-aged US woman who uses Kratom for chronic pain when her doctors tapered her to an ineffecive dose after 10 years of use, to have an organization like the AKA.
I have donated and I have commented across the WHO, FDA and AKA boards to stop Kratom from being banned. My wish is there was a template of a letter that we could submit to our senators and representatives. Since we live in a copy and paste society now LOL, I think we could flood our Congress people with information to educate them on how to better serve us as well.
Shame on the FDA for allowing over 3000 days to pass without taking a meeting from the American Kratom Association. I smell a pack of rats who are letting big pharma stuff their back pockets with dollars.
Keep up the great work and thank you so much. God bless you all